1. Field of the Invention
This invention relates generally to a medical device for placement of a purse string suture in tissue and more particularly to such a device that can also cut tissue and enable placement of a guide wire through the cut opening. More particularly, this invention relates to a method and apparatus in which living tissue is positioned using vacuum within a contoured opening located near the end of the device, which also provides for the simultaneous passage of two needles through multiple points in the held tissue. After traversing the tissue, the needles engage and pick up both ends of a segment of suture and subsequently pull the suture ends back through the targeted tissue to facilitate a reliably customized suture placement. A slidable mechanism is provided to cut the held tissue and also, when desired, to enable the passage of a guide wire through the cut opening. This invention is particularly useful for the creation of closable openings in tissue structures or for safely harvesting deeper samples from the walls of tissue structures.
2. Description of Related Art
Despite all of the advances of modern medicine, many seemingly simple patient interventions still present significant challenges regarding their safe and reliable implementation. For many patients, substantial therapeutic advantage could be offered by a technology facilitating rapid and reliable cutting open and closing of a remote tissue sites.
Efforts to improve a physician's ability to do more than just see the outer characteristics of a patient are essential to modern health care. For centuries, health care practitioners have used existing external anatomic features for gaining limited access to a patient's internal structures for diagnostic or therapeutic interventions. Without the right equipment, health care providers can only use their direct vision to view their patient's body surfaces, exposed orifices or anatomy exposed through open incisions or wounds. The use of radiographic techniques (e.g., X-ray, CT and MRI), endoscopic techniques (e.g., colonoscopy, gastroscopy, cystoscopy, bronchoscopy) and open or laparoscopic surgery, along with combinations of these modalities, now routinely provide clinically significant data and the opportunity for direct therapeutic interventions.
An endoscopic technique for viewing internal patient body cavities was first reported in 1805. Important advancements in less invasive techniques (e.g., laparoscopic surgery in 1901, flexible fiber optic endoscopes in 1957, endoscopic retrograde cholangiopancreatography (E.R.C.P) in 1968, laparoscopic cholecystectomy in 1988, etc.) helped usher in this era of modern medicine. Improvements to endoscopic technology continue to yield significant improvements in therapeutics.
Many patients could benefit from a physician's ability to gain access to internal body locations through an organ structure naturally communicating with an existing external orifice instead of through a painful incision in the skin and its underlying muscle and fascial structures. Interventions using this alternative approach have come to be called “Natural Orifice Translumenal Endoscopic Surgery” or its acronym, “NOTES,” procedures.
Examples of excellent potential access points to facilitate minimally invasive NOTES procedures include: safe entry to and exit from the peritoneal cavity through a wall of the stomach (i.e., transgastric), via the mouth, through the rectum and sigmoid colon (i.e., transcolonic), via the anus, or through the posterior fornix of the vagina (i.e., transvaginal) via the external vaginal opening. Generally, access to other body parts or compartments through the wall of a tissue structure is commonly referred to as “transmural” (i.e., through the wall) access; more specifically, gaining such access through the wall of a tubular tissue structure, from the inside (i.e., the lumen) to the outside, is commonly called an extralumenal (i.e., outside of the lumen) approach.
The proper utilization of naturally existing orifices to provide initial entry for therapeutic interventions may minimize many of the risks and morbidities of more traditional open laparotomy or laparoscopic surgery. To support a paradigm shift away from surgery requiring skin incisions, it would be helpful to have a technology, like the present invention, that could appropriately hold remote tissue, reliably provide a suture to subsequently secure it closed, safely cut it and to enable the placement of a temporary guide wire to facilitate easier instrument passage.
In the American Journal of Surgery, April 1944, Drs. Decker and Cherry published a manuscript describing a procedure they “termed culdoscopy.” They reported use of the “vaginal route” to access the peritoneal cavity for viewing internal structures and for instrument manipulations. They presented the “Decker culdoscope” and a “trochar and cannula set” for “puncturing the posterior vaginal wall.” Examples of the transmural procedures they reported include rupture of small cysts, biopsy of ovaries, testing the fallopian tubes for patency and tubal ligation for sterilization.
A recent resurgence of interest in the transmural NOTES procedures has lead to several new reports regarding the use of this approach in mostly animal experimental models. A gastroscopic “pancreatic necrosectomy” procedure was presented the internationally renowned “Digestive Disease Week” conference in 2003. This presentation reported the use of a gastroscopic instrumentation to exit through the stomach and debride a pancreas of necrotic tissue. At the “Digestive Disease Week” conference in 2004, investigators presented their “successful peroral transgastric ligation of fallopian tubes . . . in a survivor porcine model.” Other investigators presented transgastric biliary surgery, including the removal of a gallbladder from a pig. While the use of an instrument called the Eagle Claw V (Olympus Medical Systems Corportion, Tokyo, Japan) was reported for transgastric suturing of intraperitoneal tissue structures like a splenic artery; it was not used to close the transmural access site. Other investigators suggested the use of computer-controlled robots to aid in transgastric surgery. A conclusion stated, “clearly, there is a need for better instrumentation.”
Academic leaders in this area wrote an authoritative publication entitled, “ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery—White Paper—October 2005.” They reviewed recent porcine research and noted a report of a human transgastric appendectomy. While the paper mostly highlighted the per oral transgastric approach, they also mentioned the promise of the transcolonic and transvaginal access. These expert laparoscopic surgeons and endoscopists “(A)ll agreed that Translumenal Endoscopic Surgery could offer significant benefits to patients such as less pain, faster recovery, and better cosmesis than current laparoscopic techniques.” They stated, “(I)t seems feasible that major intraperitoneal surgery may one day be performed without skin incisions. The natural orifices may provide the entry point for surgical interventions in the peritoneal cavity, thereby avoiding abdominal wall incisions.”
This Natural Orifice Translumenal Endoscopic Surgery—White Paper identified “ten critical areas that will impact the safety of NOTES.” The first two areas listed by these authors are directly addressed by the present invention. From “Table 2. Potential Barriers to Clinical Practice,” the first and second listed areas are, respectively, “Access to peritoneal Cavity” and Gastric (intestinal) closure.” They state that while the “most important areas of initial study are . . . safe peritoneal access and secure gastric closure,” the “optimal techniques to do so . . . are unknown.”
The long term results of recent efforts to endoscopically suture the native lining of remote tissue sites to achieve tissue thickening and/or tightening (i.e., in medical terms, a “plication”) have proved to be relatively disappointing. Clinical investigations exploring such suture-mediated changes to tissue have typically shown excellent short-term realization of the desired symptom relief. However, without any other wound closure site preparation, over time, the sutures alone tend to loose their ability to hold tissue together for thickening or tightening. Examples of encouraging short termed success, but later disappointment, are included in most of the published clinical study's of the use of the ESD™, Endoscopic Suturing Device (manufactured by LSI SOLUTIONS®, Victor, N.Y.) or the EndoCinch® (manufactured by Bard®, Bellarica, Mass.); the encouraging early relief from endoscopically placed suture alone (without site preparation) at the distal esophagus in patients with gastroesophageal reflux disease or at the dilated surgically created stomach to small bowel connections (i.e., gastrojejunal anastomoses) in gastric bypass patients usually faded completely within two years.
Thousands of patients suffering from gastroesophageal reflux disease (GERD) have undergone endoscopic suturing using commercially available products in conjunction with gastroscopy. Despite highly encouraging initial symptom relief, most patients progressively returned to their baseline state of “heart burn” or other discomfort over weeks or months following their procedure. Without proper healing, living tissue tends to return to its prevailing state. Sutures or surgical staples alone typically can only provide a temporary mechanical arrangement to promote tissue healing. In most cases, the body has to respond and take over the functional process. Almost all patients receiving suture thickening and tightening of their esophagus adjacent to the stomach only had a few stitches placed to bulk up and narrow the native lining (called the mucosa) of the esophagus against itself. Over time, the bodies of these patients overcame the presence of the foreign material (i.e., the suture) and the walls of their distal esophagus attenuated and loosened.
Laboratory research indicates that successful long-term plication to thicken and tighten the distal esophagus is more achievable by stimulating the tissue to actually heal into the desired configuration, instead of relying solely on sutures to hold the tissue in position. Research in our porcine laboratory indicated that methods using tissue cutting or burning to promote healing at distal esophageal wound closure sites were worthy of further study. A study, entitled, “Mucosal Apposition in Endoscopic Suturing,” published by colleagues at the Cleveland Clinic, Cleveland, Ohio, reported promising results through the use of cauterizing the esophageal mucosa prior to suturing. Excellent clinical results were also reported in pediatric GERD patients who received cautery mediated wound site preparation to take away the protective mucosal lining of the esophagus and expose the inner healing tissues in preparation prior to ESD suturing.
For some bariatric patients with failed gastric bypass procedures, the endoscopic use of suturing to narrow the opening between the reduced stomach and its outflow into the by-passed small bowel has only produced acceptable, durable improvements in patients who have also received suturing site preparation to remove some mucosa and stimulate the underlying tissue to realize long term healing. Dr. Christopher Thompson's pioneering team in Boston report the largest series of patient amelioration by using suture to reduce the diameter of the connection between the functional stomach and small bowel. Their satisfactory results only came after improving their anastomotic tightening technique to also include suture site preparation.
To achieve long-term tissue thickening and tightening, tissue closure site preparation is required in addition to suture fixation. A device that facilitates remote tissue site preparation for healing and reliable suture mediated site closure could offer a substantial improvement to the therapeutic options for many patients.
Another example of the need for better technology for remote tissue cutting and closing is evident from the fact that currently many patients still often require more extensive and dangerous surgery to remove certain intestinal lesions (e.g., abnormal growths, like polyps) that extend deeper than the superficial layer lining the intestine. Many superficial intestinal lesions reached using standard intestinal endoscopy equipment and techniques can be routinely completely removed endoscopically from the intestinal wall using a wire snare. Because of the lack of effective technology and techniques, typical deeper lesions cannot yet be safely removed using this non-surgical approach.
Patients who present with larger or deeper potentially intramural intestinal lesions usually would benefit from having part of the intestinal wall immediately adjacent to the base of the lesion also removed with the lesion. While removing some of the surrounding normal intestinal tissue can ensure that the lesion is more adequately removed, the risk of harvest site leakage or impaired wound healing substantially increases if the wound is not adequately closed. Currently available technology fails to provide a safe and reliable option for the completely endoscopic removal of deep-seated internal pathologic lesions. This second preferred embodiment holds promise for eliminating the need for some patients to have to go to the surgical operating room instead of just finishing the endoscopy in the endoscopy suite with the safe and complete removal of these deeper lesions.
To provide better patient outcomes, improved technologies are needed to continue to reduce the invasiveness and potential morbidity of opening and closing holes remotely made inside of patients. While the ability to remotely cut or open and close the walls of tubular tissue structures along with the use of translumenal therapeutic interventions offer exciting potential improvements to patient care, excellent technology is needed to make this promising opportunity into clinical reality. This innovation represents a significantly means to help a broader population of patients.